Postural Tachycardia SyndromeNCT00581633
Acute Salt Handling in Orthostatic Intolerance
A study testing normal saline (0.9%) in people with Postural Tachycardia Syndrome and Orthostatic Tachycardia, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome, Orthostatic Tachycardia, Orthostatic Intolerance
- What is being tested?
- normal saline (0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)
Who cannot join
- Overt or acute cause for orthostatic tachycardia
- Hypertension (BP>145/95 or need for anti-hypertensive medications)
- QRS duration > 120 msec on EKG
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Renal Salt Handling in Orthostatic Intolerance
The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.
Read the detailed description
Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt \& water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.
- Being tested
- normal saline (0.9%)
- Keywords
- saline, sodium, kidney, tachycardia
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline (0.9%)Other
liter normal saline over 30 minutes x 1 dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | saline infusion for sodium loading Receives: Other: normal saline (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Na excretion
Measured: 24h and then hourly post saline load
Secondary outcomes (1)
Catecholamine levels
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581633
- Sponsor's protocol ID
- 061230
- Other IDs
- UL1RR024975, K23RR020783, P01HL056693
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2007
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Renal Salt Handling in Orthostatic Intolerance
- ClinicalTrials.gov ID
- NCT00581633
- Acronym / sponsor ID
- 061230
- Keywords
- saline, sodium, kidney, tachycardia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2007
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.
Detailed description
Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt \& water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: normal saline (0.9%)saline infusion for sodium loading |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)
Key exclusion criteria (4 listed)
- Overt or acute cause for orthostatic tachycardia
- Hypertension (BP>145/95 or need for anti-hypertensive medications)
- QRS duration > 120 msec on EKG
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal saline (0.9%)liter normal saline over 30 minutes x 1 dose | Other | 1 |
Primary outcome
Urinary Na excretion
Time frame: 24h and then hourly post saline load
1 secondary outcome
Catecholamine levels
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Vanderbilt Autonomic Dysfunction CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish R Raj, MD MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline (0.9%) in people with Postural Tachycardia Syndrome and Orthostatic Tachycardia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Na excretion (time frame: 24h and then hourly post saline load). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.